Obeticholic Acid for Prevention in Barrett's Esophagus
Public ClinicalTrials.gov record NCT04939051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.
Study identification
- NCT ID
- NCT04939051
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Esophageal Biopsy Procedure
- Esophagogastroduodenoscopy Procedure
- Liver Ultrasonographic Elastography Procedure
- Obeticholic Acid Biological
- Placebo Administration Drug
- Questionnaire Administration Other
Procedure · Biological · Drug + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2, 2024
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
- Last update posted
- Aug 10, 2026
2024 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | Recruiting |
| Case Western Reserve University | Cleveland | Ohio | 44106 | Recruiting |
| Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04939051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04939051 live on ClinicalTrials.gov.